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Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)

Primary Purpose

Benign Prostatic Hyperplasia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Thulium Fibre Laser
MOSES Holmium Laser
Sponsored by
Thunder Bay Regional Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males over 50 years of age at the time of enrollment
  2. Referred to urology for refractory LUTS or urinary retention secondary to BPH
  3. Failed medical (non-surgical) treatment
  4. Prostate size on preoperative TRUS of≥80 ml
  5. IPSS >15 and QOL score ≥3 and Qmax <15 ml/sec
  6. Written informed consent to participate in the study
  7. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

  1. Previous surgical treatment for BPH
  2. History of prostate cancer
  3. Prostate size < 80 mL
  4. History of urethral stenosis or its management
  5. Known or suspected neurogenic bladder
  6. Participants with active urinary tract infection until appropriately treated
  7. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
  8. Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent

Sites / Locations

  • Thunder Bay Regional Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thulium Fibre Laser (TFL)

MOSES Holmium Laser

Arm Description

Patients randomized to this arm will undergo treatment using the TFL.

Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.

Outcomes

Primary Outcome Measures

Length of stay in the hospital

Secondary Outcome Measures

Incidence of bleeding
Incidence of blood transfusion
Operative time
Including laser use time
International Prostate Symptom Score
Eight questions (seven concerning urinary symptoms and one concerning quality of life), responses range from 0 (better outcome) to 5 (worse outcome), with total score ranging from 0 to 35.
Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)
Response to the last question on the IPSS: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible'.
Peak flow rate
Qmax
Post-void residual
PVR
Prostate specific antigen
PSA
Change in size
Assessed by TRUS
Time to Catheter Removal

Full Information

First Posted
January 7, 2022
Last Updated
April 20, 2022
Sponsor
Thunder Bay Regional Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05240001
Brief Title
Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)
Official Title
Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser Enucleation of the Prostate for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thunder Bay Regional Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Benign prostatic hyperplasia (BPH), the non-cancerous enlargement of the prostate, places pressure on the urethra and causes urination and bladder problems. Transurethral Resection of the Prostate (TURP) remains the gold standard treatment in most centres for BPH. However, morbidity after TURP is high, especially bleeding requiring blood transfusion and late postoperative bleeding. Holmium laser enucleation of the prostate (HoLEP) is a safe and effective procedure which has demonstrated comparable results to TURP. HOLEP also offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. The main reason HoLEP has yet to become the new standard for treatment of symptomatic BPH is due the complexity of this procedure as compared to TURP. Furthermore, the HoLEP can be used with the MOSESTM system, a system that allows for more efficiency and ease of use of the HoLEP. Thulium fiber laser (TFL) enucleation of the prostate is an emerging technology for endoscopic prostate enucleation that is notable for its high wavelength and pulsed mode of action. Recent studies have shown TFL enucleation of the prostate to be a safe and highly efficacious treatment modality for the management of large volume (> 80 cm3) glands in BPH. Due to its novelty, further studies are needed to broaden the investigators' understanding of the TFL and comprehend the full implications and benefits of this new technology, as well its limitations. The aim of this study is to whether Thulium Fiber laser enucleation of the prostate (ThuFLEP) and Holmium laser enucleation using MOSES™ (M-HoLEP) have comparable length of hospital stay, as well as intraoperative and postoperative outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thulium Fibre Laser (TFL)
Arm Type
Experimental
Arm Description
Patients randomized to this arm will undergo treatment using the TFL.
Arm Title
MOSES Holmium Laser
Arm Type
Experimental
Arm Description
Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.
Intervention Type
Device
Intervention Name(s)
Thulium Fibre Laser
Intervention Description
Participants will undergo treatment using the TFL
Intervention Type
Device
Intervention Name(s)
MOSES Holmium Laser
Intervention Description
Participants will undergo treatment using the MOSES Holmium laser.
Primary Outcome Measure Information:
Title
Length of stay in the hospital
Time Frame
within 6 hours
Secondary Outcome Measure Information:
Title
Incidence of bleeding
Time Frame
Intra-Op
Title
Incidence of blood transfusion
Time Frame
Intra-Op
Title
Operative time
Description
Including laser use time
Time Frame
Intra-Op
Title
International Prostate Symptom Score
Description
Eight questions (seven concerning urinary symptoms and one concerning quality of life), responses range from 0 (better outcome) to 5 (worse outcome), with total score ranging from 0 to 35.
Time Frame
1,3,6,12 months post-op
Title
Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)
Description
Response to the last question on the IPSS: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible'.
Time Frame
1,3,6,12 months post-op
Title
Peak flow rate
Description
Qmax
Time Frame
1,3,6,12 months post-op
Title
Post-void residual
Description
PVR
Time Frame
1,3,6,12 months post-op
Title
Prostate specific antigen
Description
PSA
Time Frame
1,3,6,12 months post-op
Title
Change in size
Description
Assessed by TRUS
Time Frame
6 months
Title
Time to Catheter Removal
Time Frame
within 4 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males over 50 years of age at the time of enrollment Referred to urology for refractory LUTS or urinary retention secondary to BPH Failed medical (non-surgical) treatment Prostate size on preoperative TRUS of≥80 ml IPSS >15 and QOL score ≥3 and Qmax <15 ml/sec Written informed consent to participate in the study Ability to comply with the requirements of the study procedures Exclusion Criteria: Previous surgical treatment for BPH History of prostate cancer Prostate size < 80 mL History of urethral stenosis or its management Known or suspected neurogenic bladder Participants with active urinary tract infection until appropriately treated Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rabail Siddiqui, MPH, MHSc
Phone
(807) 684-6608
Email
siddiqur@tbh.net
First Name & Middle Initial & Last Name or Official Title & Degree
Hazem Elmansy, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazem Elmansy, MD
Organizational Affiliation
Thunder Bay Regional Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabail Siddiqui, MPH, MHSc
Email
siddiqur@tbh.net

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)

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